{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-08-03",
    "results": {
      "skip": 0,
      "limit": 1,
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    }
  },
  "results": [
    {
      "has_donation_id_number": "false",
      "mri_safety": "Labeling does not contain MRI Safety Information",
      "record_status": "Published",
      "is_labeled_as_nrl": "false",
      "is_rx": "false",
      "commercial_distribution_status": "In Commercial Distribution",
      "device_description": "Blood Pressure Monitor Replacement Cuffs Large",
      "public_device_record_key": "18ad14c8-24b7-4474-a2c9-858ee79e5b40",
      "has_serial_number": "false",
      "public_version_date": "2025-10-06",
      "sterilization": {
        "is_sterile": "false",
        "is_sterilization_prior_use": "false"
      },
      "is_direct_marking_exempt": "true",
      "public_version_number": "3",
      "labeler_duns_number": "047025993",
      "is_labeled_as_no_nrl": "false",
      "identifiers": [
        {
          "id": "10818323024613",
          "type": "Package",
          "issuing_agency": "GS1",
          "unit_of_use_id": "00818323024616",
          "quantity_per_package": "80",
          "package_status": "In Commercial Distribution",
          "package_type": "Case"
        },
        {
          "id": "00818323024616",
          "type": "Primary",
          "issuing_agency": "GS1"
        }
      ],
      "is_single_use": "false",
      "is_otc": "true",
      "version_or_model_number": "DMD1038GRYL",
      "has_manufacturing_date": "false",
      "brand_name": "Vive Precision",
      "is_combination_product": "false",
      "is_kit": "false",
      "product_codes": [
        {
          "code": "DXQ",
          "name": "Blood Pressure Cuff",
          "openfda": {
            "device_name": "Blood Pressure Cuff",
            "medical_specialty_description": "Cardiovascular",
            "regulation_number": "870.1120",
            "device_class": "2"
          }
        }
      ],
      "premarket_submissions": [
        {
          "submission_number": "K171889",
          "supplement_number": "000"
        }
      ],
      "device_count_in_base_package": "1",
      "is_pm_exempt": "false",
      "has_lot_or_batch_number": "false",
      "company_name": "VIVE HEALTH LLC",
      "public_version_status": "Update",
      "has_expiration_date": "false",
      "is_hct_p": "false",
      "gmdn_terms": [
        {
          "code": "34978",
          "name": "Blood pressure cuff, reusable",
          "definition": "A band-like device that has an inflatable bladder in an inelastic sleeve with one or two connecting tubes with connector (typically locking connectors) that can be connected to a mechanism for inflating and deflating the bladder and/or a sphygmomanometer or a patient monitoring device/system that is used to determine a patient's blood pressure. It is wrapped around the upper arm or the leg (thigh) of the patient. This is a reusable device which may be intended for single-patient or multi-patient reuse.",
          "implantable": "false",
          "code_status": "Active"
        }
      ],
      "publish_date": "2018-09-13"
    }
  ]
}